Endovascular Engineering ENGULF Study

Completed · Not applicable

Conditions studied: Pulmonary Embolism

In brief

Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).

Key facts

Study ID

NCT05597891

Run by

Endovascular Engineering

People needed

177

Starts

2023-01-12

Expected to finish

2026-03-30

Last updated by the study team

2026-04-14

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet ALL of the following criteria to be eligible for participation in the study:
• *Patient is > 18 and < 90 years old
• *Clinical signs and symptoms consistent with acute submassive PE with duration ≤ 14 days, as determined by the Investigator
• (*)CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
• (*)RV/LV ratio of ≥ 0.9 (Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio at baseline)
• *Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
• *Heart rate < 130 BPM prior to procedure
• *Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
• Patient signs a written Informed Consent form to participate in the study, prior to any study mandated procedures

You may not qualify if…

• Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met:
• *Acute massive PE at presentation
• *Prior PE within last 6 months
• *Thrombolytic use within 30 days of baseline CTA
• *Pulmonary hypertension with peak pulmonary artery systolic pressure > 70 mmHg by right heart catheterization
• *Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
• *FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
• *Hematocrit < 28% (NOTE: hematocrit required within 24 hours of index procedure)
• *Platelets < 100,000/μL
• *Serum creatinine > 1.8 mg/dL
• *International normalized ratio (INR) > 3
• *aPTT (or PTT) > 50 seconds on no anticoagulation
• *Major trauma < 14 days
• *Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
• *Cardiovascular or pulmonary surgery within last 7 days
• *Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
• *Known bleeding diathesis or coagulation disorder
• *Known left bundle branch block
• *History of severe pulmonary arterial hypertension
• *History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
• *History of uncompensated heart failure
• *History of underlying lung disease that is oxygen dependent
• *Presence of IVC filter and or iliocaval stents
• *History of heparin-induced thrombocytopenia (HIT)
• *Any contraindication to systemic or therapeutic doses of heparin or anticoagulants

Where it is running

• PIH Health Good Samaritan Hospital — Los Angeles, California, United States
• Huntington Hospital — Pasadena, California, United States
• The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• Torrance Memorial Medical Center — Torrance, California, United States
• Delray Medical Center — Delray Beach, Florida, United States
• Baptist Health Research Institute — Jacksonville, Florida, United States
• HCA Florida Memorial Hospital — Jacksonville, Florida, United States
• Piedmont Heart — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• TriHealth Hatton Research Institute — Cincinnati, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Wellmont Cardiology Services / Ballad Health — Kingsport, Tennessee, United States
• Tennova Healthcare - Turkey Creek Medical Center — Knoxville, Tennessee, United States
• Austin Heart — Austin, Texas, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• UT Health — Houston, Texas, United States
• Gundersen Health — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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